BIVARIATE SEQUENTIAL DESIGNS FOR PHASE-II TRIALS

In this paper we propose methods for designing group sequential phase II trials with two dependent binary endpoints. The emphasis is on the derivation of stopping rules for phase II trials which require the enr ollment of a small number of patients. The methods are based on enumer ating the exact distribution for the binary endpoints. We illustrate t he methods with a recent study which required the use of a group seque ntial design to monitor antitumor activity and toxicity.